EP2104462A2 - Nichtinvasive ultraschallgestützte körperkonturierung mit hautkontaktkühlung - Google Patents

Nichtinvasive ultraschallgestützte körperkonturierung mit hautkontaktkühlung

Info

Publication number
EP2104462A2
EP2104462A2 EP07827423A EP07827423A EP2104462A2 EP 2104462 A2 EP2104462 A2 EP 2104462A2 EP 07827423 A EP07827423 A EP 07827423A EP 07827423 A EP07827423 A EP 07827423A EP 2104462 A2 EP2104462 A2 EP 2104462A2
Authority
EP
European Patent Office
Prior art keywords
frequency
ultrasound
variable
control unit
ultrasound emitter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP07827423A
Other languages
English (en)
French (fr)
Other versions
EP2104462A4 (de
Inventor
Paul K. Perl
Francisco Arriaza Munoz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from ES200700339U external-priority patent/ES1064835Y/es
Priority claimed from ES200700340U external-priority patent/ES1064836Y/es
Application filed by Individual filed Critical Individual
Publication of EP2104462A2 publication Critical patent/EP2104462A2/de
Publication of EP2104462A4 publication Critical patent/EP2104462A4/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0245—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with ultrasonic transducers, e.g. piezoelectric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/54—Control of the diagnostic device
    • A61B8/546—Control of the diagnostic device involving monitoring or regulation of device temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00026—Conductivity or impedance, e.g. of tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00106—Sensing or detecting at the treatment site ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0207—Characteristics of apparatus not provided for in the preceding codes heated or cooled heated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0214—Characteristics of apparatus not provided for in the preceding codes heated or cooled cooled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0221—Mechanism for heating or cooling
    • A61H2201/0242—Mechanism for heating or cooling by a fluid circulating in the apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0221—Mechanism for heating or cooling
    • A61H2201/025—Mechanism for heating or cooling by direct air flow on the patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/02—Characteristics of apparatus not provided for in the preceding codes heated or cooled
    • A61H2201/0221—Mechanism for heating or cooling
    • A61H2201/0285—Mechanism for heating or cooling with Peltier elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/10—Characteristics of apparatus not provided for in the preceding codes with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0008—Destruction of fat cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0073—Ultrasound therapy using multiple frequencies

Definitions

  • the present invention relates to devices and methods for non-invasive ultrasound-guided body contouring using skin contact cooling for use in medical therapies and cosmetic treatments for the human body by lysing adipose tissue.
  • Eshel US Patent No. 6,607,498 (hereinafter referred to as Eshel '498), teaches a device having a directional head, including one or more ultrasound emitters, that can produce beneficial vibrational and cavitational effects in a patient's superficial and internal tissues.
  • Eshel '498 focused ultrasound energy is administered at a pre-determined power and frequency that can be adjusted from a control unit connected to the device head. The adjustment is performed manually according to the treatment to be administered and the area to be treated.
  • the appropriate energy to be applied is typically determined by the operator or therapist, and thus, depends on their expertise and experience.
  • the effect of the ultrasound therapy on lysing adipose tissue is not known at the time of treatment.
  • Determining the resonant frequency enables the operator or therapist to optimize the treatment results to the patient during treatment, to avoid excessive exposure to the patient of unutilized energy, and to prevent harmful side effects that can result from inappropriate treatment conditions. There is a risk that the applied power may be too high to produce a given effect. This can result in local inflammation due to excessive cavitation or overheating by friction. Current methods attempt to avoid such situations from occurring by treating the patient on a frequent basis in short sessions, inconveniencing the patient by wasting time in making multiple visits with partial results.
  • variable-frequency treatment applicator is specifically defined for use herein to refer to an applicator that can output a frequency that is continuously variable over a frequency range, meaning that the output frequency that the applicator emits is continuously variable in real time.
  • Embodiments of the present invention use a treatment applicator having one or more variable-frequency ultrasound emitters to adjust the output energy, either automatically or manually, to the resonant frequency detected for each patient via a resonance sensor.
  • the treatment applicator includes a low- and mid-frequency electro-stimulation electrode.
  • the treatment applicator includes at least one insulated high-frequency stimulation electrode, either resistive or capacitive.
  • the device includes a resonance sensor of the energy administered by the ultrasound emitters, allowing for the measurement and evaluation of the amount of absorbed and reflected energy.
  • the resonance sensor is connected to a control module to determine the working frequency that provides the highest efficiency of power with the patient's tissue.
  • the device scans the entire working frequency range, and measures the frequency at which the supplied ultrasound is most efficient (via the resonance sensor).
  • the optimal frequency corresponds to the resonant frequency of the energy applied to the tissue in the specific area of the patient's anatomy, and ensures better therapeutic results, while reducing exposure to unutilized energy.
  • the resonance sensor may be located in a separate device head, independent of the treatment applicator in which the ultrasound emitters are located.
  • a device for non-invasive ultrasound-guided body contouring including: (a) a variable-frequency treatment applicator having at least one variable- frequency ultrasound emitter; and (b) a control unit for adjusting an output frequency of at least one ultrasound emitter.
  • the treatment applicator has at least two ultrasound emitters configured to be operated sequentially.
  • the output frequency is within a frequency range from 20 kHz to 100 kHz.
  • the output frequency is within a frequency range from 25 kHz to
  • control unit is configured to provide the output frequency in a continuous-wave mode.
  • control unit is configured to provide the output frequency in a burst-cycle mode.
  • control unit is configured to sweep the output frequency over a designated frequency range and a designated time interval.
  • the treatment applicator includes at least one electro-stimulation electrode.
  • a device for non-invasive ultrasound-guided body contouring including: (a) a variable-frequency treatment applicator having at least one variable-frequency ultrasound emitter; (b) a resonance sensor for determining a resonant frequency of a treatment area; and (c) a control unit for adjusting an output frequency, of at least one ultrasound emitter, to the resonant frequency based on a signal from the resonance sensor, .
  • the resonance sensor is located in the treatment applicator.
  • the resonance sensor is located in a separate head independent of the treatment applicator.
  • the output frequency is within a frequency range from 25 kHz to 6O kHz.
  • control unit is configured to provide the output frequency in a continuous-wave mode.
  • control unit is configured to provide the output frequency in a burst-cycle mode.
  • control unit is configured to sweep the output frequency over a designated frequency range and a designated time interval.
  • the treatment applicator includes at least one electro-stimulation electrode.
  • a device for non-invasive ultrasound-guided body contouring using skin contact cooling including: (a) a variable-frequency treatment applicator having at least one variable-frequency ultrasound emitter; (b) a cooling mechanism located in the treatment applicator; and (c) a control unit for applying an output frequency to at least one ultrasound emitter.
  • the cooling mechanism is configured to pass a coolant through at least one channel in at least one ultrasound emitter.
  • the cooling mechanism is configured to be controlled by an thermo-electric cooler.
  • a method for non-invasive ultrasound-guided body contouring including the steps of: (a) providing a variable-frequency treatment applicator having at least one variable-frequency ultrasound emitter; and (b) adjusting, using a control unit, an output frequency of at least one ultrasound emitter.
  • a method for non-invasive ultrasound-guided body contouring including the steps of: (a) providing a variable-frequency treatment applicator having at least one variable-frequency ultrasound emitter; (b) determining, using a resonance sensor, a resonant frequency of a treatment area; and (c) adjusting, using a control unit, an output frequency, of at least one ultrasound emitter, to the resonant frequency based on a signal from the resonance sensor.
  • a method for non-invasive ultrasound-guided body contouring using skin contact cooling including the steps of: (a) providing a variable-frequency treatment applicator having at least one variable-frequency ultrasound emitter; (b) cooling at least one ultrasound emitter; and (c) applying, using a control unit, an output frequency of at least one ultrasound emitter.
  • Figure 1 shows a perspective view of the ultrasound-guided body-contouring device, according to preferred embodiments of the present invention
  • Figure 2A shows a partial cut-away view of the treatment applicator of the device, according to preferred embodiments of the present invention
  • Figure 2B shows an end view of the skin-contacting surface of the treatment applicator of Figure 2A, according to preferred embodiments of the present invention.
  • FIG. 1 shows a perspective view of the ultrasound-guided body-contouring device, according to preferred embodiments of the present invention.
  • a treatment applicator 10 is connected to a control unit 12 via a connection cable 14.
  • An ultrasound emitter 16 e.g. a piezoelectric element
  • Control unit 12 can be used to sweep the output frequency of ultrasound emitter 16 over a pre-determined range of frequencies.
  • a resonance sensor 18 (e.g. using ultrasound-imaging or impedance-measurement techniques) is connected to control unit 12, and is used to regulate the output frequency and power of ultrasound emitter 16. During a sweep of the output frequency of ultrasound emitter 16 by control unit 12, resonance sensor 18 determines the resonant frequency. Control unit 12 uses the resonant frequency as the working frequency for ultrasound emitter 16, optimizing treatment with minimum power. Alternatively, control unit 12 can also continue to sweep the output frequency of ultrasound emitter 16 in a narrow range centered on the resonant frequency, hi other preferred embodiments, resonance sensor 18 is located in a head (not shown) that is independent of treatment applicator 10.
  • control unit 12 is configured such that treatment applicator 10 delivers ultrasonic emission over a wide range of frequencies (e.g. 20-500 kHz). In preferred embodiments, a working frequency range of ultrasonic emission from 25 to 60 kHz is employed. Control unit 12 activates and controls a single piezoelectric element (i.e. ultrasound emitter 16) to provide ultrasound emission.
  • a single piezoelectric element i.e. ultrasound emitter 16
  • Ultrasound emitter 16 can be operated in sweeping- or resonant-frequency mode, as well as in a continuous- wave or burst-cycle mode, hi the sweeping- frequency mode, a frequency range is chosen, and control unit 12 constantly changes the frequency at pre-determined time intervals continuously.
  • the sweeping-frequency mode enables the depth of treatment to be controlled.
  • the frequency is fixed at the determined resonant frequency which depends on the volume, density, and depth of the fat tissue being treated in order to produce effective cavitational bubbles, hi order to optimize the effectiveness of the treatment, the resonant frequency associated with the fat tissue has to be determined that does not cause an effect on the surrounding tissue.
  • hi the continuous-wave mode ultrasound emission is applied to the treatment area continuously.
  • control unit 12 operates in an on/off duty cycle to provide a variety of treatment pulses in order to create a greater amount of micro-bubbles. Furthermore, such burst-mode operation can create shock waves due to localized pressure gradients, enhancing the effectiveness of the treatment.
  • Resonant absorption of the ultrasound emission depends on the cavity size of the tissue being treated, the density of the tissue, and the depth of the tissue.
  • the resonant frequency is determined manually or automatically by control unit 12 using the data signal from resonant sensor 18 in treatment applicator 10.
  • the micro-bubbles created in the fat tissue due to the exposure to the ultrasound emission, lyse the adipose tissue due to pressure changes when expanding and collapsing (due to both micro-jet and heating effect below the skin surface with no undesirable heating effect at the skin-contact surface).
  • a coolant circulating in cooling lines 20 is used to dissipate the heat generated by ultrasound emitter 16 in a skin-contact cooling-mode via a thermo-electric cooler 22.
  • Thermo-electric cooler 22 is connected to treatment applicator 10 via cooling lines 20 to supply the cooling at all times to the circulating chamber of ultrasound emitter 16. Such cooling is especially important when the device is operating at non-resonant frequencies and/or in continuous-wave mode.
  • an electro-stimulation electrode 24 is mounted on treatment applicator 10 for providing enhanced treatment capabilities. Electro-stimulation electrode 24 applies a low- to mid-frequency (e.g. 5 to 500 Hz) current in order to stimulate and contract the tissue in order to enhance the cavitational effect. Electro-stimulation electrode 24 can also be configured to supply a current in the RF frequency range (e.g. 1 to 10 MHz) in an electrically-isolated probe.
  • FIG. 2A shows a partial cut-away view of the treatment applicator of the device, according to preferred embodiments of the present invention, hi preferred embodiments, treatment applicator 10 is configured to provide localized treatments.
  • Treatment applicator 10 is shown in Figure 2A with a lower portion of a housing 28 removed to reveal the internal components of treatment applicator 10.
  • Thermo-electric cooler 22, via cooling lines 20, provides cooling, which can be regulated for a desired temperature, to ultrasound emitter 16 via a circulating jacket 30.
  • Circulating jacket 30 is preferably made of aluminum or another light thermally- conductive material. Coolant, flowing through cooling lines 20, flows through a cooling channel 32 in ultrasound emitter 16.
  • FIG. 2B shows an end view of the skin-contacting surface of the treatment applicator of Figure 2 A, according to preferred embodiments of the present invention.
  • Resonance sensor 18 and electro-stimulation electrode 24 are shown within housing 28 outside the region of ultrasound emitter 16.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Radiology & Medical Imaging (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Rehabilitation Therapy (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Plasma & Fusion (AREA)
  • Otolaryngology (AREA)
  • Surgical Instruments (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)
  • Percussion Or Vibration Massage (AREA)
EP07827423A 2007-02-16 2007-11-25 Nichtinvasive ultraschallgestützte körperkonturierung mit hautkontaktkühlung Withdrawn EP2104462A4 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ES200700339U ES1064835Y (es) 2007-02-16 2007-02-16 Dispositivo terapeutico aplicador de energia
ES200700340U ES1064836Y (es) 2007-02-16 2007-02-16 Dispositivo aplicador de energia ajustable
PCT/IL2007/001450 WO2008099376A2 (en) 2007-02-16 2007-11-25 Non-invasive ultrasound-guided body contouring using skin contact cooling

Publications (2)

Publication Number Publication Date
EP2104462A2 true EP2104462A2 (de) 2009-09-30
EP2104462A4 EP2104462A4 (de) 2009-11-04

Family

ID=39690599

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07827423A Withdrawn EP2104462A4 (de) 2007-02-16 2007-11-25 Nichtinvasive ultraschallgestützte körperkonturierung mit hautkontaktkühlung

Country Status (6)

Country Link
US (1) US20100198064A1 (de)
EP (1) EP2104462A4 (de)
JP (1) JP2010534076A (de)
KR (1) KR20100031652A (de)
IL (1) IL192706A0 (de)
WO (1) WO2008099376A2 (de)

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EP2104462A4 (de) 2009-11-04
WO2008099376A2 (en) 2008-08-21
WO2008099376A3 (en) 2009-05-28
JP2010534076A (ja) 2010-11-04
US20100198064A1 (en) 2010-08-05
IL192706A0 (en) 2009-02-11

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